Apparatus and method for the reduction of pain using vibration, cold and distractive elements

ABSTRACT

A device for reduction of pain, comprising a casing comprising a flexible sheet of material having a first end and a second end; at least one thermal source associated with the casing; a fastener for removably joining the first end and the second end; at least one vibration source; at least one power source; at least one switch for actuating the at least one vibration source, the at least one vibration source, the at least one power source and the at least one switch being in electrical communication with each other. The device further includes a distraction aid in the form of a still or animated image associated with the casing which can distract the patient from the perception of pain.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation-in-part of copending application Ser. No. 11/538,718, filed Oct. 4, 2006, entitled DEVICE AND METHOD FOR THE REDUCTION OF PAIN ASSOCIATED WITH NEEDLE STICKS, and commonly assigned to the assignee of the present application, the disclosure of which is incorporated by reference in its entirety herein

TECHNICAL FIELD

The present invention generally relates to devices and methods for the reduction of pain, such as that associated with needle sticks as well as other forms of acute or chronic pain. The present invention further relates to a device using vibration or a combination of vibration, cold and/or distractive elements that is applied to a patient for the reduction of the pain, for example, prior to and/or during the application of a needle or other sharp to the patient. Also disclosed are methods for using the device, and methods for using vibration or a combination of vibration, cold and/or distractive elements for the reduction of the pain. The foregoing characterization of the invention is meant solely for the purpose of establishing the technical field of the invention and is not intended to fully describe or limit the scope of the invention or the embodiments.

BACKGROUND

Transitory, acute and ongoing pain reduction and management have been the subject of many studies and efforts. Transitory pain may be the result of localized trauma or nerve activation, or the like. Needle sticks, such as for injection, are one such cause. According to many children, needle sticks are the most painful procedure performed in the hospital. The effects of untreated pain are remembered even by children too young to talk. Fear of needles and immunizations affect children's other healthcare experiences and parents' willingness to have them immunized. Needle phobia does not end in childhood. Some geriatric patients cite it as a reason not to get a flu shot. Some human immunodeficiency virus (HIV) patients say it is a reason for delaying being tested. While the avoidance of obtaining dental care due to needle phobia is legendary, less well known is that up to 75% of adults cite needle pain as a reason not to donate blood.

Needle phobia is not isolated to the United States. In a survey asking for a blood sample for a study, 38% of adults in Singapore cited fear of needles and injections as their reason not to participate.

Effective means to decrease needle pain include local analgesia, distracting the patient, and confusing the nerves. Topical analgesics can reduce or eliminate needle pain, but may cost between US$12 and US$150 per patient use. In addition, topical analgesics require prolonged application times or can cause vasoconstriction decreasing venipuncture success. Several devices deliver lidocaine using either electrical current (iontophoresis) or ultrasound, but the cost for these starts at US$50 per delivery and can take up to 10 minutes.

The nerve fibers that transmit pain also transmit cold and vibration senses. Vibrating the skin while injecting lidocaine has long been used to decrease the pain of dental injections, but vibrating needles have not been found to be effective in other dermal situations. Use of a simple hand-held vibrating massager has decreased injection pain in adults, but has been used alone without the adjuvant of cold therapy and has not been tested in children.

The related art devices generally are designed to be used at the site of the needle pain to deliver lidocaine (local anesthetic), rather than several centimeters proximal to the site. Further, none of the related devices incorporates the application of cold. Applying cold or vibration at the site, or immediately proximal to the site, can create logistical problems for the medical practitioner, and can cause a heightened anxiety in the patient, by requiring a plurality of devices to be located in a single location. Thus, such devices have a disadvantage.

Therefore, there is a need for device to decrease the pain associated with immunization, infiltration, injection and venipuncture, which would include both cold and vibration stimulation. Such a device should be reusable, easy to clean, tolerable to children and adults, and should incorporate a method to be adapted for use in the developing world (for example, operation with a power cord, with a battery, with a solar or light cell, with a wind-up motor, or without the need for external power).

Distraction of the patient from the impending or present pain (or anticipation of such) is another known technique (in addition to vibration and cold) for alleviating or preventing pain, particularly in children. It would be desirable for a device intended for pain reduction to have a mechanism or component which might include bright colors, attraction-getting ornamental designs, still or animated images, or simple tasks.

Accordingly, there is a need for a method for reducing of the pain associated with hypodermic needle sticks and other transitory, acute and chronic pain. There also is a need for a device and method using vibration or a combination of vibration and cold that is applied to a patient prior to and/or during the application of a hypodermic needle to the patient for the reduction of the pain associated with the application of the hypodermic needle. It is to these needs and others that the present invention is directed.

SUMMARY

One aspect of the present disclosure provides a device for reduction of pain comprises a casing comprising a flexible sheet of material having a first end and a second end; at least. one thermal source associated with the casing; a fastener for removably joining the first end and the second end; at least one vibration source; at least one power source; at least one switch for actuating the at least one vibration source, the at least one vibration source, the at least one power source and the at least one switch being in electrical communication with each other. The device further includes a distraction aid in the form of a still or animated image associated with the casing which can distract the patient from the perception of pain.

Another aspect of the present disclosure provides a device for reduction of pain, comprising: a casing comprising a flexible sheet of material having a first end and a second end; at least one thermal source associated with the casing; a fastener for removably joining the first end and the second end; at least one vibration source; at least one power source; at least one switch for actuating the at least one vibration source, the at least one vibration source, the at least one power source and the at least one switch being in electrical communication with each other. This aspect of the present invention may also include a distraction aid comprising an image or other indicia associated with the device and capable of attracting the attention of a patient.

Another aspect of the present disclosure provides a method for reducing pain, comprising the steps of: a) providing a device comprising a casing having an application area, at least a portion of the application area constructed to contact a subject's skin; b) providing a thermal source contained within the casing, the thermal source capable of being cooled, and cooling the thermal source; c) providing a vibrational source contained within the casing, the vibrational source capable of producing vibration; d) contacting the application area to the subject's skin; e) activating the vibrational source so that the vibrational source produces vibrations; f) maintaining the thermal source and the vibrational source on the patient's skin for a time period; and, g) providing a distraction aid associated with the device so that the subject is able to see the distraction aid, wherein the application area is constructed to allow the transmission of cold from the thermal source to the subject's skin and the transmission of the vibration from the vibrational source to the subject's skin, whereby after contacting the application area to the subject's skin and activating the vibrational sources, cold and vibration is transmitted to the subject via the application area, whereby the combination of the transmission of cold and vibration produces a thermal analgesia and vibrational analgesia effect on the subject and the presence of distraction aid so as to reduce pain.

These and other features of the present disclosure will become more apparent to those of ordinary skill in the relevant art when the following detailed description of exemplary embodiments is read in conjunction with the appended drawings in which like reference numerals represent like components throughout the several views.

BRIEF SUMMARY OF THE DRAWINGS

FIG. 1 is a perspective view of an exemplary embodiment of the invention.

FIG. 2 is a top view of an embodiment of the invention with both vibration and cold capabilities.

FIG. 3 is a bottom view of an embodiment of the invention with both vibration and cold capabilities.

FIG. 4 is sectional side view of the embodiment of the invention as shown along line 4-4′ of FIG. 2.

FIG. 5 is a circuit diagram of an embodiment of the invention.

FIG. 6 is a perspective view of an embodiment of the invention having an ornamental cover or casing.

FIG. 7 is a perspective view of another exemplary embodiment of the present invention.

FIG. 8 is a perspective exploded view of the exemplary embodiment shown in FIG. 7.

FIG. 8A is a perspective view of the exemplary embodiment shown in FIG. 7.

FIG. 9 is a top plan view of the exemplary embodiment shown in FIG. 7.

FIG. 10 is a perspective view of a cover as part of the exemplary embodiment shown in FIG. 7.

FIG. 11 is a top plan view of the exemplary embodiment shown in FIG. 7 with a cold source in position around the pedestal.

FIG. 12 is a top plan view of an alternative exemplary embodiment having a U-shaped member.

FIG. 13 is a top plan view of another alternative exemplary embodiment having a ring-shaped member.

FIG. 14 is a top plan view of a further alternative exemplary embodiment having a V-shaped member.

FIG. 15 is a top plan view of another alternative embodiment.

DETAILED DESCRIPTION

Exemplary embodiments of the invention now will be disclosed in conjunction with the appended figures. FIG. 1 is a perspective view of an embodiment of the invention. FIG. 2 is a top view of an embodiment of the invention with both vibration and cold capabilities. FIG. 3 is a bottom view of an embodiment of the invention with both vibration and cold capabilities. FIG. 4 is sectional side view of the embodiment of the invention as shown along line 4-4′ of FIG. 2. FIG. 5 is a circuit diagram of an embodiment of the invention. FIG. 6 is a perspective view of an embodiment of the invention having an ornamental cover or casing that can act as an additional distraction to the patient.

“Hypodermic needles” as used herein includes, but is not limited to, all different types of needles, pins, probes, sharps and the like that can be used to inject, remove, or apply fluids, medications and the like to a patient, as well as to conduct tests such as but not limited to allergy tests to a patient.

“Thermal analgesia” as used herein includes, but is not limited to, the use or application of cold or reduced temperature (or the removal of heat) to a patient to induce an analgesic effect.

“Vibrational analgesia” as used herein includes, but is not limited to, the use or application of vibration to a patient to induce an analgesic effect.

“Vibrational and thermal analgesia” as used herein includes, but is not limited to, the use or application of both cold or reduced temperature (or the removal of heat) concurrently, substantially concurrently, or sequentially with the use or application of vibration to a patient to induce an analgesic effect.

Referring now to FIG. 1, a perspective view of an exemplary embodiment of the device 10 of the present invention is shown as applied to the arm 100 of a patient, showing the casing 12 housing the various components of the invention and an optional strap 14 for holding the device 10 to the patient. The casing 12 preferably is manufactured of a flexible or pliant material, such as for illustrative purposes a natural or synthetic woven or non-woven fabric, a rubber or other flexible polymer material, or a silicone-based material, to provide an enclosed structure. Other flexible or pliant or other materials may be employed, and it is preferred that the material of construction is non-toxic, hypo-allergenic and non-staining to the patient.

The casing 10 can be any shape, and preferably is in the shape of a three-dimensional polygon (for use with an adult use) or an animal or other distractive shape (for use with a child) and having a hollow interior or interior sections for containing the operating elements of the invention. Any other shape (as used herein, the term shape is used in the broad sense of three-dimensional works) may be employed, so long as the shape is large enough and structured so as to be able to contain the various working components of the invention as more fully disclosed below.

The device is shown in FIG. 1 applied to the arm 100 of a patient to whom a hypodermic needle 102 is being applied. As disclosed in more detail below, the positioning of the device 10 on the patient is between the needle prick site 104 and a nerve plexi (not shown, but the location of which is known to those of ordinary skill in the pain alleviation field) between the needle stick site 104 and the spinal cord or brain, in this example at or proximal to the elbow E. Thus, in FIG. 1, the device 10 is place farther up the arm 100 of the patient from the needle prick site 104, which, in the placement of the needle stick site 104 in FIG. 1, is closer to the elbow E than to the wrist W. Preferably, the device 10 is placed approximately 2.5 cm to 15 cm from the needle prick site 104, more preferably, 1 cm to 5 cm.

Referring now to FIG. 2, a top view of an embodiment of the invention is shown. A minimal embodiment of the external features of the invention comprises the casing 12 and an on/off switch 16. Optional strap 14 can be used to hold the device 10 on to the patient. Alternatively, the device 10 can be held against the patient by the practitioner, the practitioner's assistant, or the patient. Strap 14 can be attached to the casing 12 in any conventional manner or can be an extension of casing 12 itself. For example, strap 14 and casing 12 can be attached together much like a conventional watch and watchband with hinges or pins. For another example, strap 14 can be an extension of the fabric or other material of casing 12. The ends of strap 14 preferably have some type of connecting device, such as a hook and loop fastener 18, a clasp, a clip, snaps, magnets, or the like for attaching the device about the patient's body part. Alternatively, if the ends of strap 14 are flexible, the ends can be tied together around the patient's body part.

Referring now to FIG. 3, a bottom view of an embodiment of the invention is shown. The casing 12 has a peripheral bottom rim 20 that defines an application area generally designated 22 in FIG. 3. Application area 22 comprises thermal area 24 and vibration area 26. Although thermal area 24 and vibration area 26 area shown as discrete areas in FIG. 3, this is for illustrative purposes only, as there need not be any physical delineation between thermal area 24 and vibration area 26 and application area 22. As disclosed in more detail below, thermal source 28 cooperates with thermal area 24 to apply cold to the patient, and vibrational source 32 cooperates with vibration area 26 to apply vibration to the patient. Thermal area 24 and vibrational area 26 can be coextent.

Thermal source pocket 34 is a slot, fold or other type of compartment in casing 12 into which thermal source 28 can be placed. As shown in FIG. 3, thermal source pocket 34 is accessed on the side of the casing 12 via a mouth 36. Alternatively, mouth 36 can be located at other locations on casing 12 depending on the size and shape of casing 12 and the location of the vibrational source 32 within the casing 12. Alternatively, thermal source 28 can be contained within the main housing volume of casing 12. Thus, the placement of thermal source 28 is variable so long as the cooling effects of thermal source 28 can be felt on the patient so as to produce thermal analgesia. Thermal area 24 in its simplest form is an area on the application area 22 on the device 10 that allows the thermal effects (cold) from thermal source 28 to contact the patient.

Vibration area 26 is a pad or other area on casing 12 in vibratory contact with vibrational source 32. As disclosed in more detail below, vibrational source 32 preferably is contained within the main housing volume of casing 12. The placement of vibrational source 32 is variable so long as the vibration effects of vibrational source 32 can be felt on the patient so as to produce vibrational analgesia. As shown in FIG. 3, vibrational area 26 is proximal to thermal area 24; however, vibrational area 26 can coextend with thermal area 24. Vibrational area 26 in its simplest form is an area on the application area 22 on the device 10 that allows the vibrations from vibrational source 32 to contact the patient.

Referring now to FIG. 4, a sectional side view of the embodiment of the invention as shown along line 4-4′ of FIG. 2 is shown. Casing 12 is a generally hollow structure sized to contain thermal source 28 and vibrational source 32. More specifically, casing 12 can be a rigid hollow case having an interior volume or a flexible or pliant case having an interior volume. Such cases are known, as well as their materials and methods of construction. In this embodiment the casing 12 can be constructed such that casing can contain and hold thermal source 28 and vibrational source 32 in a predetermined position relative to the patient when the invention is applied to the patient.

As shown illustratively in FIG. 4, thermal source 28 is contained in thermal source pocket 34. Thermal source 28 can be placed within thermal source pocket through mouth or opening 36 and can be held within thermal source pocket 34 by friction, adhesives, fasteners, or by a zipper or other type of closure on mouth or opening 36. It is preferable that the bottom wall 38 of thermal source pocket 34 be sufficiently thin or have sufficient thermal transfer characteristics so as to allow the efficient transfer of cold from thermal source 28 to the patient.

Thermal source 28 can be any conventional thermal source capable of storing and transferring cold (removing heat). Illustrative examples of suitable thermal sources 28 include metal ingots, low freezing point (below about 45° F. or 7.2° C.) liquids and gels, ceramics, polymers, other heat sinks, Peltier devices, chemicals which when combined produce an endothermic reaction, and ice. Such thermal sources 28 are known. It is only important that thermal source 28 be able to transfer cold to the patient in a sufficient amount so as to produce thermal analgesia. For example, providing a temperature of below about 45° F. or 7.2° C., and preferably between about 28° F. or −2.2° C. and about 54° F. or 12.2° C., and more preferably between about 38° F. or 3.3° C. and about 45° F. or 7.2° C., to the patient prior to and during the needle stick is sufficient to provide a suitable level of thermal analgesia. The thermal source 28 is applied to the patient for a time period sufficient to initiate thermal analgesia, which can be between 0 seconds and several minutes or more depending on the patient. However, it is preferable to apply the thermal source 28 to the patient for a period of about 0 to 60 seconds, and preferably between about 10 second and about 60 seconds, prior to the needle stick and continuing during the needle stick to provide a suitable level of thermal analgesia.

As shown illustratively in FIG. 4, vibrational source 32 is contained within the interior of casing 12. Vibrational source 28 can be placed within casing 12 during manufacture or, if casing 12 has an ingress and egress means, such as a zipper or other closure, at any time after manufacture. An ingress and egress means is preferred, as one embodiment of vibrational source 32 utilizes a battery as the power source 40, and it may be necessary to change the battery on occasion. Vibrational source 28 and power source 40 can be held within casing 12 by friction, adhesives, fasteners, or other types of securing means. Alternatively, the interior volume of casing 12 can be approximately the same dimensions as the vibrational source 28, including the power source 40, such that additional means for securing the vibrational source 28 are unnecessary. It is preferable that the bottom wall 38 of casing proximal to vibrational source 32 be sufficiently thin or have sufficient vibrational transfer characteristics so as to allow the efficient transfer of vibration from vibrational source 28 to the patient.

Vibrational source 32 can be any conventional vibrational source or means for producing vibrations. As shown in FIG. 4, vibrational source 32 further comprises a power source 40 and wiring 42 electrically connecting vibrational source 32 and power source 40 to on/off switch 16. Illustrative examples of suitable vibrational sources 32 include elliptical flywheel motors, eccentric motors, and the like. Such vibrational sources 32 are known. It is only important that vibrational source 32 be able to transfer vibration to the patient at a sufficient level to produce vibrational analgesia. For example, providing vibrations of between about 300 vibrations per minute and about 9000 vibrations per minute, preferably between about 3700 vibrations per minute and about 6000 vibrations per minute, and more preferably between about 4400 vibrations per minute and about 5800 vibrations per minute, to the patient prior to and during the needle stick is sufficient to provide a suitable level of vibrational analgesia. The vibrational source 32 is applied to the patient for a time period sufficient to initiate vibrational analgesia, which can be between 0 seconds and several minutes or more depending on the patient. However, it is preferable to apply the vibrational source 32 to the patient for a period of about 0 seconds to about 60 seconds, preferably between about 5 seconds and about 30 seconds, and more preferably between about 5 seconds and about 10 seconds prior to the needle stick, and continuing during the needle stick to provide a suitable level of vibrational analgesia.

Vibrational source 32 can produce a single vibrational cycle, multiple vibrational cycles, or be variable. In other words, vibrational source 32 can be a vibrational motor that operates at, for example, 4700 vibrations per minute or, for another example, at 5700 vibrations per minute. Alternatively, vibrational source 32 can be a vibrational motor that operates at two or more vibrational cycles, for example, 4700 vibrations per minute and 5700 vibrations per minute, and can be switched between vibrational cycles by a switch or other mechanism. Alternatively, vibrational source 32 can be a vibrational motor that operates at many different vibrational cycles along a continuum by using a potentiostatic switch, for example, vibrational source 32 can be varied continuously or step-wise between 3000 vibrations per minute and 6000 vibrations per minute.

Switch 16 can be a common switch and is used to turn vibrational source 32 on and off, namely to start and stop the vibration, respectively. Switch 16 can be secured to casing 12 at any convenient position where it may readily be actuated. Switch 16 is electrically connected in a known manner between the power source 40 and the vibrational source 32 to control the application of power to the vibrational source 32. Thus, when the vibrational source 32 is switched on, the vibrating force produced from the vibrational source, such as the various types of motors disclosed above, will be transmitted through the casing 12 to apply on the body of the patient.

Switch 16 can be a common on/off switch, such as a toggle, lever, push-button, capacitance or other switch. This type of switch 16 would be practical with a single vibrational cycle motor. Alternatively, switch 16 can be a common three-way switch. This type of switch 16 would be practical with a double vibrational cycle motor. Alternatively, switch 16 can be a common potentiostat. This type of switch 16 would be practical with a vibrational motor that operates at many different vibrational cycles along a continuum.

Referring now to FIG. 5, a representative circuit diagram for the vibrational source 32 is shown. Vibrational source 32, power source 40 and on/off switch 16 are electrically connected in series by wiring 42. Power source 40 is illustrated in FIG. 5 as a battery; however, power source 40 can be any type of power sources such as but not limited to a connection to an alternating current source (a wall plug), a solar or other light cell, a reactor, a mechanical source such as a flywheel or springs, or the like. It is only important that power source 40 be able to provide sufficient power to vibrational source 32 so as to produce sufficient vibration for effecting vibrational analgesia.

In operation and use, the device helps to counter infiltration pain through the use of vibrational and thermal analgesia. According to known gate theory, vibration helps to reduce pain as the vibrational, or motion, nerves surmount the pain nerves. Similarly, it is known that cold helps to reduce pain as the temperature nerves surmount the pain nerves. It also is known that vibrational and thermal analgesia is more effective when applied generally between the pain source and the brain, and more specifically close to the nerve plexi where the various nerve types (pain, temperature and motion) converge in the body, generally at or proximal to a joint.

The following example of use will describe a medical procedure as this is a preferred use for the device 10. However, it should be understood that the device can be used in many other situations where pain is to be reduced.

The thermal source 28 is cooled, if necessary. For example, if the thermal source 28 is a metal ingot or low freezing point gel, the thermal source 28 is placed in a refrigerator, freezer, or other cold site. When the thermal source 28 is of a satisfactory temperature, the thermal source 28 is placed within the casing 12, such as within the thermal source pocket 34. After a doctor or other medical practitioner has determined where on the patient's body a needle stick will occur, the device 10 is applied to the body at a location between the needle stick site 104 and the patient's brain, along the nerve path. In the example shown in FIG. 1, the needle stick site 104 is proximal to the patient's wrist W. Therefore, the device 10 generally is placed between the needle stick site 104 and the patient's brain, and more specifically in the illustrative example shown in FIG. 1, is placed between the needle stick site 104 and the patient's elbow E and proximal to the nerve plexi proximal to the elbow. For example, the placement of the device 10 generally is within about 2.5 cm to about 15 cm of the needle stick site 104, which range of location often will encompass the nerve plexi. Preferably, the needle stick site 104 can be selected so as to be within 15 cm of the closest nerve plexi.

The device 10 with the thermal source 28 is applied to the selected area of the patient such that the application area 22, comprising the thermal area 24 and the vibrational area 26, contact the patient's skin. The thermal source 28 is allowed to act upon the patient for a suitable time period so as to initiate thermal analgesia. Once suitable thermal analgesia is achieved, or concurrently when the thermal source is applied to the patient, the vibrational source 32 is actuated by the switch 16, creating vibration. The vibrational source 32 also is allowed to act upon the patient for a suitable time period so as to initiate vibrational analgesia. After thermal analgesia and vibrational analgesia are initiated, the medical practitioner can apply the needle 102 to the patient. The thermal source 28 and the vibrational source 32 are allowed to continue to act upon the patient during the needle stick activity.

After the needle 102 has been applied to and removed from the patient, the entire device 10 can be removed and/or just the thermal source 28 can be removed from the device 10 and therefore from acting on the patient, and/or the vibrational source 32 can be turned off and therefore from acting on the patient. However, the device 10, including the active thermal source 28 and the active vibrational source 32, can be left in contact with the patient after the needle stick activity has ended, for example in situations where needle stick pain persists, for a time period sufficient to maintain thermal and/or vibrational analgesia. In one illustrative method, the device 10 is left in contact with the patient for a period of between 0 and 60 seconds, preferably between 5 and 30 seconds, and more preferably between 5 and 10 seconds, to continue to reduce any pain associated with the needle stick.

Referring now to FIG. 6, alternative embodiments include casings 12 having interesting or distracting shapes. Distraction also is known to help reduce pain, especially to children. For example, the casing 12 could be a flexible material in the shape of a bumble bee, as illustrated in FIG. 6, or dinosaur. When the device 10 is applied to a child, the distracting shape both can lessen the fear a child may have to the device 10 and help to decrease the subsequent pain of the needle stick.

The exemplary embodiments described herein above may further comprise the use of removable and interchangeable covers and casings, such as different animal shapes and various colors, textures and the like, such that the device can be changed to please the patient. For example, while a young child may prefer or be better distracted by a green dinosaur shaped casing, and adult may not care and a plain blue casing would be sufficient.

Referring now to FIG. 7, an exemplary embodiment device 100 has a casing 102 which houses several components. The casing 102 is preferably made of a generally rigid material, such as, but not limited to, plastic, polymer, metal, ceramic, alloy, and combinations and mixtures of the foregoing. It is preferred that the material of construction is non-toxic, hypo-allergenic and non-staining to the patient.

The casing 102 can be any shape, and may be in the shape of a three-dimensional polygon (for use with an adult use) or an animal or other distractive shape (for use with a child). Any other shape (as used herein, the term shape is used in the broad sense of three-dimensional works) may be employed, so long as the shape is large enough and structured so as to be able to contain the various working components of the invention as more fully disclosed below.

The casing 102 includes a recess area 104 forming a well which can accommodate a power source 106. The casing 102 may have a lid 108 (see FIG. 8) which may be hingedly associated with the casing 102, such as, but not limited to, a pair of pins 110 which fit into a pair of mating recesses or detents 112 in the casing 102. The lid 108 may also have a closure 114 which can detachably lock with a mating closure recess 116 in the case 102.

The casing also preferably has a pair of side flanges 120, 122. A casing cover 124 (see FIG. 10) has an upper face 126 and a pair of side lips 128, 130 which can slidably mate with the casing side flanges 120, 122 so that the casing cover 124 covers the recess area 104 and adjacent areas.

The casing 102 also has an opening 140 which may receive a switch 142. The switch 142 may be a switch as described hereinabove with respect to switch 16. The switch 142 may be secured to the casing 102 in the opening 140 with the switch activation portion (e.g., rocker portion) outside of the casing 102 by rivets (not shown), glue, welding, snap fit, friction fit, tongue and groove or other attachment technique known to those skilled in the art.

At least one power source 106 fits inside the recess area 104. The power source 106 may be one or more conventional alkaline, NiCad, lithium ion, or nickel metal hydride batteries or other power source. It may be electrically connected to the switch 142 by a conventional contact plate 144 associated with the casing 102, or may be connected by wires in a conventional manner. Where a rechargeable power pack is used the present invention may also optionally include a recharger base (not shown) which can receive at least a portion of the casing. Recharging may be achieved by induction, such as is known to those skilled in the art.

Alternatively, instead of a battery power source 106, the power source may be a wind-up motor disposed in the recess area 104 and having a crank attached thereto and extending through the casing 102. Alternatively, the power source 106 may be an AC power cord having a plug attached to the end which may be connected to a conventional wall outlet. Alternatively, the power source 106 may be a solar cell or photovoltaic cell on the casing cover 124 or otherwise associated with the device 100.

Optionally, the casing 102 may have a ledge 146 which can protect the switch 142 from being accidentally actuated.

A skin contact member 150 extends from one end of the casing 102. The contact member may be fixedly or removably attached to the casing 102. The contact member 150 facilitates the transmission of cold and vibration from the device 100 to a patient's skin or other contact area.

In one exemplary embodiment, shown in FIGS. 7-9, the contact member is a hollow pedestal 152 extending from the body of the casing 102. The pedestal 152 may have an access opening 154 (see FIG. 8) which can be accessed through the casing opening 140. The pedestal 152 may optionally have at least one vent opening 156. The pedestal 152 also has a base surface 158. In one exemplary embodiment the pedestal 152 is shaped generally as a truncated cone, tapering with the narrower end proximate to the casing 102. The base surface 158 may be flat, convex or concave curved, and may be textured, ribbed, grooved, have nibs, or have other surface texture. The pedestal may optionally further include a notch or groove (not shown) to secure an external cold back, such as by twisting or clicking into place.

At least one vibration source 160 is disposed within the pedestal 152. The vibration source 160 may comprise any conventional mechanism or motor which can generate vibrational energy, as described hereinabove.

Vibration source 160 can be placed within the pedestal 152 during manufacture, or, the pedestal 152 has an opening through which the vibration source 160 may be inserted there through into the hollow interior of the pedestal 152.

Vibration source 160 can be held within pedestal 152 by friction, adhesives, fasteners, mounting bracket, mounting tabs, or other types of securing means. Alternatively, the interior volume of the pedestal 152 can be approximately the same dimensions as the vibration source 160, including such that additional means for securing the vibration source 160 are unnecessary. It is preferable that the bottom surface 158 of the pedestal 152 be sufficiently thin or have sufficient vibrational transfer characteristics so as to allow the efficient transfer of vibration from vibrational source 160 via the bottom surface 158 to the patient. The vibration source 160 is in electrical communication with the power source 106 or the switch 142 by means of wiring 162, a contact plate (not shown) or other electrical connection. The vibration source 160 may have similar characteristics of the vibration source 32 described hereinabove.

Thus, when the switch 142 is actuated, power source 106 provides power to the vibrational source 160 and vibrating force produced from the vibrational source, such as the various types of motors disclosed above, will be transmitted through the casing 102 to apply on the skin of the patient.

This exemplary embodiment further includes a source of cold that will contact the patient's skin. At least one thermal cold source 170 may be a container filled with ice, gel, powder, granules (or other particles), chemicals which when mixed produce cold, mixtures of the foregoing or other sources of cold known to those skilled in the art. Alternatively, the cold source 170 may be a solid block of material shaped as needed. Alternatively, the pedestal 152 may be made of material that itself can be chilled, such as by placing in a freezer or refrigerator. Alternatively, the cold source 170 may be a Peltier device disposed within the casing 102 and in electrical communication with the power source 106 as well as in thermal communication with the pedestal 152.

In one exemplary embodiment, as shown in FIG. 11, the cold source 170 is a torus-shaped gel pack which can fit around at least a portion of the pedestal 152. The cold source chills the pedestal 152. The pedestal 152 may be made of a thermally conductive material, such as, but not limited to, metal, plastic, alloy, composite or the like. It may be the same material as the casing 102 or of different material.

In an alternative exemplary embodiment the skin contact member 150, rather than being the pedestal 152, can be one of several different shapes, shown in FIGS. 12-15. FIG. 12 shows a U-shaped member 180 which can be associated at the base of the U with the casing 102 in an area where the pedestal 152 would otherwise be by a connector 181. In this embodiment the U-shaped member 180 has at least one “coin” shaped vibration motor 182 mounted within (or on the outside of) the arm of the U. In this embodiment, the switch can be the switch 142, or, alternatively, instead of the switch 142, a switch 184 may mounted on the U-shaped member 180 and in electrical communication with the power source 106. The U-shaped member 180 is sized to accommodate a finger width, or may be sized to accommodate a limb or other body part (ear lobe, or the like).

An another alternative exemplary embodiment, shown in FIG. 13, the skin contact member 150 is a ring-shaped member 190, which may have at least one “coin” shaped vibration motor 182 mounted within (or on the outside of) the ring.

In the embodiments shown in FIGS. 12 and 13, a cold source 170 may be the torus-shaped container as described hereinabove which removably fits around the U-shaped member 180 or the ring-shaped member 190.

In another alternative exemplary embodiment, shown in FIG. 14, the skin contact member 150 may be a pair of arms 200, 202 pivotably connected by a pivot pin 204. The pin 204 may be associated with the casing 102. The arms 200, 202 may have a slot which each can receive an ingot 206 which is made of a thermally conductive material that may be chilled. The arms 200, 202 may each also house a coin motor 182 as the vibration source.

In another alternative exemplary embodiment, shown in FIG. 15, a device 300 comprises a cuff 302 having a first end 304 and second end 306. The cuff 302 may be made of a relatively flexible material, such as plastic, polymer, fabric or the like. The ends 304, 306 may have hook and loop type fasteners 308, 310 attached thereto. The cuff 302 may be a set of cojoined cold packs 312 capable of being chilled. One or more vibration motors 314 are associated with the cuff 302 and electrically connected to a switch 316 and a power source 318. The cuff may fit around a patient's arm or other area and the cold packs 312 can chill the skin and the vibration motors 314 can vibrate at the desired area. A distraction aid 320 may comprise a still or animated image, cartoon, word(s) or combinations thereof, and may be printed or embossed on the cuff 203 or otherwise associated therewith. The distraction aid 320 may be a cover, band or sheath encompassing at least a portion of the cuff 102 and may be removable.

The present invention also preferably includes a visual aid to assist in creating distraction of the patient prior to, during, and/or after the caregiver uses the needle or during other potentially painful procedures. The visual aid may be an image placed on or associated with the casing cover 124. The visual aid may be a picture, cartoon, words or combinations of both. The visual aid may also be a screen displaying an animated image (such as, for example, a cell phone or personal digital assistant type screen and associated electronics). Alternatively, the visual aid may be a touch sensitive button with an associated task/result, such as, but not limited to, a puzzle, or other image which, when the patient touches the button, alters the image or creates a sound indicating the task is done. Performing the task assists in distracting the patient. Distraction has been found to be extremely effective at decreasing children's pain. One aspect of several embodiments of the present invention is to provide a combination of distraction, vibration and cold source to decreasing pain sensation. The cover 124 can slide off the casing 102 to be replaced or to give access to the recess area 102. The removable cover allows the distraction to be immediately seen at the location of the shot (so as to obscure the child's sight of a shot) or to be removed to distract the child away from looking at the area.

The present invention may be used in connection with needle sticks as well as many other kinds of transitory, acute, chronic or other pain conditions (or perceptions of pain). Types of acute accidental pain include, but are not limited to, stings, burns, splinters, bruises, contusions, scrapes and the like. Types of acute iatrogenic pain include, but are not limited to, iontophoresis delivery of vaccines or medicines; rehabilitation stretching; subcutaneous injections; fracture manipulation, tattoo removal or other laser treatment, hair removal, skin ablation, skin injections, acid treatment, and the like. Types of chronic pain include, but are not limited to, carpal tunnel; tennis elbow; plantar fasciitis and the like. The foregoing are intended to be illustrative and not an exhaustive list. The embodiments shown in FIGS. 7-15, and variations thereof, may be used to apply vibration and cold to the appropriate area of the skin (and nerves underneath) to provide an analgesic effect to the area which is or will about to be traumatized.

The various embodiments of the present invention may be applied proximal or distal to the point of pain with regard to the brain. The present invention may be used by a caregiver, someone else proximate to the patient, or by the patient directly.

The above detailed description of exemplary embodiments are for illustrative purposes only and are not intended to limit the scope and spirit of the invention, and its equivalents, as defined by the appended claims. One skilled in the art will recognize that many variations can be made to the invention disclosed in this specification without departing from the scope and spirit of the invention. 

1. A device for reducing pain, comprising: a) a casing comprising i. an application area, at least a portion of the application area constructed to be placed proximate to or in contact with a subject's skin, ii. a vibration source housing section, iii. a recess area for receiving a power supply, iv. a lid for covering said recess area, v. a removable cover associated with said casing; b) at least one thermal source capable of being cooled and being associated with said casing such that at least a portion of said thermal source can either directly or indirectly be placed in contact with a subject's skin; c) at least one vibration source contained within said vibration source housing section, said vibration source capable of producing vibration; and d) at least one power source for powering said vibration source, whereby the combination of the transmission of cold and vibration produces a thermal analgesia and vibrational analgesia effect on the subject so as to reduce pain.
 2. The device of claim 1, further comprising an actuator switch for activating and deactivating said vibration source.
 3. The device of claim 1, wherein said power source is either a battery, solar cell, wind-up motor, a kinetic power source, a power cord adapted for an AC wall outlet, a rechargeable power supply, or a combination of any of the foregoing.
 4. The device of claim 1, further comprising a visual distraction-creating member associated with said removable cover.
 5. The device of claim 4, wherein said visual distraction-creating member comprises an image associated with said removable cover.
 6. The device of claim 4, wherein said visual distraction-creating member comprises an animated image.
 7. The device of claim 4, wherein said visual distraction-creating member comprises at least one touch-activated button and a task area which, upon activation of said button, causes a sensory feedback signal to be actuated, thereby providing feedback to said subject that said task was completed.
 8. The device of claim 1, wherein said application area of said casing projects from said casing and said thermal source is adapted to at least partially encompass said application area.
 9. The device of claim 1, wherein said application area comprises a generally hollow pedestal associated with one side of said casing.
 10. The device of claim 9, wherein said thermal source has a torus shape and which can be fitted around said pedestal.
 11. The device of claim 1, wherein said thermal source is selected from the group consisting of a gel pack, a cold pack, a solid ingot of material capable of being cooled, ice, a chemical material that, when mixed, achieves a cooled state for an extended period of time, and, combinations of the foregoing.
 12. The device of claim 1, further comprising a strap.
 13. The device of claim 1, wherein said thermal source is a Peltier device.
 14. The device of claim 1, wherein said application area comprises a thermally conducting material.
 15. The device of claim 14, wherein said thermally conducting material comprises a sheet of polymeric film.
 16. The device of claim 1, wherein said thermal source is disposed at least partially within said casing.
 17. The device of claim 1, wherein said application area comprises a U-shaped member associated with said casing and having at least one said vibration source in said U-shaped member.
 18. The device of claim 1, wherein said application area comprises a ring-shaped member associated with said casing and having at least one said vibration source in said ring-shaped member.
 19. The device of claim 1, wherein said application area comprises a first arm and a second arm, each arm having a proximal end and a distal end, at least a portion of said first and second arms being hollow, said proximal ends being pivotably connected by a pin and said pin being associated with said casing.
 20. The device of claim 19, wherein at least one of said first and second arm contains a thermal source and a vibration source.
 21. A device for reduction of pain, comprising: a. a casing comprising a flexible sheet of material having a first end and a second end; b. at least one thermal source associated with said casing; c. a fastener for removably joining said first end and said second end; d. at least one vibration source; e. at least one power source; f. at least one switch for actuating said at least one vibration source, said at least one vibration source, said at least one power source and said at least one switch being in electrical communication with each other.
 22. The device of claim 21, further comprising a distraction aid comprising an image or other indicia associated with said device and capable of attracting the attention of a patient.
 23. The device of claim 22, wherein said distraction aid comprises a band of material which can be removably associated with said device, said band including an image.
 24. The device as claimed in claim 1, further comprising a strap for securing the device to the subject.
 25. The device as claimed in claim 1, further comprising a removable cover or casing.
 26. A method for reducing pain, comprising the steps of: a) providing a device comprising a casing having an application area, at least a portion of the application area constructed to contact a subject's skin; b) providing a thermal source contained within the casing, the thermal source capable of being cooled, and cooling the thermal source; c) providing a vibrational source contained within the casing, the vibrational source capable of producing vibration; d) contacting the application area to the subject's skin; e) activating the vibrational source so that the vibrational source produces vibrations; f) maintaining the thermal source and the vibrational source on the patient's skin for a time period; and, g) providing a distraction aid associated with said device so that the subject is able to see said distraction aid, wherein the application area is constructed to allow the transmission of cold from the thermal source to the subject's skin and the transmission of the vibration from the vibrational source to the subject's skin, whereby after contacting the application area to the subject's skin and activating the vibrational sources, cold and vibration is transmitted to the subject via the application area, and whereby the combination of the transmission of cold and vibration produces a thermal analgesia and vibrational analgesia effect on the subject and the presence of distraction aid so as to reduce pain.
 27. The method as claimed in claim 13, further comprising the step of placing the device on the subject's skin at a position proximate to the neural pathway between where pain either is occurring or will occur and the subject's brain.
 28. The method as claimed in claim 13, further comprising the step of placing the device on the subject at a position proximal to a nerve plexi on the subject. 